A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in Adult Growth Hormone Deficient patients - N/A

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2005-005587-82-SE
• Date of registration: 02/03/2006
• Prospective Registration: Yes
• Public title: A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in Adult Growth Hormone Deficient patients - N/A
• Scientific title: A Double Blind Parallel Group Randomised Multiple Dose Study to Evaluate the pharmacodynamic response and safety of Pha-794428 in Adult Growth Hormone Deficient patients - N/A
• Date of first enrolment: 12/06/2006
• Target sample size: 170
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-005587-82
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: Third party open to study site pharmacist If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Czech Republic, Denmark, Greece, Italy, Netherlands, Poland, Sweden, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male and female patients between the ages of 25-65 yrs with severe AGHD as defined by Growth Hormone Research Society (GRS) Guidelines (3). Patients may be included if they had idiopathic severe GHD in childhood, which is still present on re-testing, or if they have isolated GHD with evidence of hypothalamic/pituitary pathology.
2. Hypopituitary patients must be on adequate hormone replacement therapy for at least 6 months. Patients must be demonstrated to have adequate cortisol reserve or be on adequate glucocorticoid replacement therapy.
3. GH treated patients will have a minimum of 3 weeks washout (and not longer than 4 weeks) prior to dosing.
4. Written informed consent.
5. Patient must be willing and able to comply with scheduled visits, treatment plan,
laboratory tests and other program procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. AGHD patients with uncontrolled pituitary tumor growth. Patients with pituitary tumors must have demonstrated stable neuroimaging within 12 months of the screening visit (If MRI scan not available within the last 12 months, MRI scan must be taken at Visit 1).
2. Tumors within 3 mm of the optic chiasm. Patients with residual suprasellar disease, must be scanned within 3 months of the screening visit.
3. Serum ALT and/or AST = 1.5 times the upper limit of normal range (ULN), or clinically significant hepatic disease.
4. Patients with diabetes mellitus. Impaired glucose tolerance without drug treatment is permissible.
5. Patients who drink more than 28 units per week (1 unit = 1/2 pint of beer (285 mL) or 25 mL of spirits or one glass (125 mL) of wine).
6. Patients with a history of clinically significant allergies, especially drug hypersensitivity.
7. Patients who have evidence of drug or substance abuse.
8. Patients who have donated blood or blood products during the previous two months or intend to donate blood or blood products during the study or for two months following the completion of the study.
9. Patients who have a positive screening for HIV, Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) or anti-hepatitis C virus serology (as determined by a multi-antigen EIA).
10. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration, or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry into this trial (e.g.active malignant disease, morbid obesity BMI =40).
11. Pregnant or lactating women.
12. Female of child-bearing potential who is unwilling or unable to use adequate
contraception to prevent pregnancy during the study.
13. Concomitant therapy with other investigational drugs or participation in another clinical trial in the last 6 months.
14. Requirement to use medication during the study that might interfere with the evaluation of the study drug.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Adult Growth Hormone Deficiency
MedDRA version: 9.1 Level: LLT Classification code 10056438 Term: Growth hormone deficiency

Intervention(s)

Product Name: N/A
Product Code: PHA-794,428
Pharmaceutical Form: Powder for injection*
INN or Proposed INN: N/A
CAS Number: N/A
Current Sponsor code: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Powder for injection*
Route of administration of the placebo: Subcutaneous use

Product Name: N/A
Product Code: PHA-794,428
Pharmaceutical Form: Powder for injection*
INN or Proposed INN: N/A
CAS Number: N/A
Current Sponsor code: N/A
Other descriptive name: Pegylated polypeptide hormone of human recombinant origin PEG-hGH
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Powder for injection*
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Primary end point(s): Responder status at visits 9 (week 4) and 14 (week 7), where responder is defined as a patient who has achieved an IGF-1 level above the mid-point of the age-related normal range.

Main Objective: Main objectives:

To explore the safety, toleration and humoral response of PHA-794428 after multiple weekly injections in AGHD patients.

To explore the dose response relationship of PHA-794428 after multiple weekly subcutaneous injections in AGHD patients.

To explore the PK/PD relationships with PHA-794428 after single and multiple injections.

Secondary Objective:

Secondary ID(s)

A6391003

N/A

Secondary Sponsor(s)

Pfizer AB

Pfizer Ltd